A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Complicated Urinary Tract Infection

Last updated: May 15, 2025
Sponsor: Menarini Group
Overall Status: Active - Recruiting

Phase

2

Condition

Urinary Tract Infections

Kidney Failure

Kidney Disease

Treatment

Meropenem plus vaborbactam

Clinical Study ID

NCT06828848
VABOR-KIDS-01
2024-514656-32-00
  • Ages 3-17
  • All Genders

Study Summary

The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem ( fixed combination of meropenem and vaborbactam) in the paediatric population aged from 3 months to < 18 years with complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) in need of hospitalisation and intravenous (IV) antibiotic administration.

All participants will receive Vaborem IV every 8 hours to treat cUTI and/or AP for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of Vaborem. PK sample collection will occur after at least 6 doses administration.

Participant's clinical conditions will be monitored during the entire duration of their hospitalization and during scheduled visit/s after the completion of the treatment.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Written informed consent before initiation of any study-related procedures.

  • Male or female, 3 months and < 18 years of age, inclusive.

  • Require hospitalization for cUTI/AP and a minimum of 3 days of IV antibiotictreatment for cUTI/API as per Investigator's judgement.Current or suspected cUTI orAP as indicated by the presence of clinical signs and symptoms, and complicatingfactors.

Exclusion

Main Exclusion Criteria:

  • History of any moderate or significant hypersensitivity or allergic reaction tobeta-lactam antibiotics or to any component of the investigational medical product.

  • cUTI/AP that in the opinion of the Investigator is unlikely to respond to the studytreatment.

  • Creatinine clearance <50 mL/min.

  • In treatment with immunosuppressive agents, valproic acid, or probenecid.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Meropenem plus vaborbactam
Phase: 2
Study Start date:
February 18, 2025
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Fakultni nemocnice Ostrava

    Ostrava,
    Czechia

    Active - Recruiting

  • Faculty Hospital Kralovske Vinohrady, Paediatric Clinic

    Prague,
    Czechia

    Active - Recruiting

  • Hôpital mère-enfant - CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • Nice University Hospital (CHU de Nice)

    Nice,
    France

    Active - Recruiting

  • Hospital Armand Trousseau Clinical Research Site

    Paris,
    France

    Active - Recruiting

  • CHRU de Tours Hôpital Clocheville Clinical Research Site

    Tours,
    France

    Active - Recruiting

  • Giannina Gaslini Institute

    Genoa,
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù

    Rome,
    Italy

    Active - Recruiting

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    Warsaw,
    Poland

    Active - Recruiting

  • Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)

    Łódź,
    Poland

    Active - Recruiting

  • Hospital Sant Joan de Deu

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz,
    Spain

    Active - Recruiting

  • Hospital Dr Josep Trueta

    Girona,
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Málaga

    Malaga,
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela,
    Spain

    Active - Recruiting

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